Aphakia, Cataract
Conditions
Keywords
Light Adjustable Lens, Intraocular lens, LAL
Brief summary
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.
Interventions
Primary eye will receive Light adjustable lens with Light delivery Device treatments
DEVICEControl IOL
Fellow eye will receive control IOL
Sponsors
RxSight, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Select post operative assessments will be performed on both the experimental and control eye by an examiner who will be masked to the eye assignments.
Intervention model description
All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of an intraocular lens (IOL). * Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. * History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes. * Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/40 or worse with or without a glare source in both eyes. * Willing and able to comply with the requirements for study specific procedures and visits. * Able to complete a written questionnaire in English.
Exclusion criteria
* Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye. * Pre-existing macular disease in either eye. * Patients with sufficiently dense cataracts that preclude examination of the macula in either eye. * History of uveitis in either eye. * Evidence of ectasia in either eye. * Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus. * Subjects taking systemic medication that may increase sensitivity to UV light. * Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen. * History of ocular herpes simplex virus in either eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | Postop Month 6 |
| Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | Postop Month 6 |
| One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5% | Postop Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected Distance Visual Acuity (UCDVA) | Postop Month 6 |
| Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination | Postop Month 6 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments | 105 |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.
Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments | 105 |
| Control IOL A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL | 105 |
| Control IOL A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.
Control IOL: Fellow eye will receive control IOL | 105 |
| Total | 420 |
Baseline characteristics
| Characteristic | Control IOL | Total | Light Adjustable Lens (LAL) and Light Delivery Device (LDD) |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 6.9 | 64.2 years STANDARD_DEVIATION 6.9 | 64.2 years STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Eyes | 24 Eyes | 12 Eyes |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Eyes | 186 Eyes | 93 Eyes |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Eyes | 0 Eyes | 0 Eyes |
| Eye OD Eye | 53 Eyes | 105 Eyes | 52 Eyes |
| Eye OS Eye | 52 Eyes | 105 Eyes | 53 Eyes |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Asian | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Black or African American | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) More than one race | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) Unknown or Not Reported | 0 Eyes | 0 Eyes | 0 Eyes |
| Race (NIH/OMB) White | 105 Eyes | 210 Eyes | 105 Eyes |
| Region of Enrollment United States | 105 Eyes | 210 Eyes | 105 Eyes |
| Sex: Female, Male Female | 60 Eyes | 120 Eyes | 60 Eyes |
| Sex: Female, Male Male | 45 Eyes | 90 Eyes | 45 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 105 |
| other Total, other adverse events | 48 / 105 | 38 / 105 |
| serious Total, serious adverse events | 1 / 105 | 0 / 105 |
Outcome results
Primary
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | 0.269 Diopter | Standard Deviation 0.269 |
| Control IOL | Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control | 0.379 Diopter | Standard Deviation 0.338 |
Primary
Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | -0.319 Diopter | Standard Deviation 0.319 |
| Control IOL | Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control | -0.452 Diopter | Standard Deviation 0.456 |
Primary
One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
Time frame: Postop Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5% | 100 percent of eyes w. BCDVA 20/40 or better |
Secondary
Uncorrected Distance Visual Acuity (UCDVA)
Time frame: Postop Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Uncorrected Distance Visual Acuity (UCDVA) | 0.002 logMAR | Standard Deviation 0.108 |
| Control IOL | Uncorrected Distance Visual Acuity (UCDVA) | 0.052 logMAR | Standard Deviation 0.13 |
Secondary
Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
Time frame: Postop Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) | Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination | -0.003 mean logMAR UCDVA | Standard Deviation 0.113 |
| Control IOL | Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination | 0.061 mean logMAR UCDVA | Standard Deviation 0.139 |